Maxcon Two Gallon Chemotherapy Container
FDA 510(k) clearance K180983 · decided 2019-01-03
Clearance details
- K-number
- K180983
- Device name
- Maxcon Two Gallon Chemotherapy Container
- Applicant
- Ningbo Maxcon Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-04-13
- Decision date
- 2019-01-03
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- MMK
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ningbo, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.